title: Distribution of reported StarClose SE vascular closure device complications in the manufacturer and user facility device experience database.
abstract: OBJECTIVE
  To evaluate the type and frequency of complications associated with the StarClose SE vascular closure device reported to the U.S. Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database for comparison with complications reported in clinical trials.
  
  
  METHODS
  Complications reported in the MAUDE database related to use of the StarClose SE vascular closure device were reviewed. Keyword searches by device and manufacturer were performed for a 16-month period from July 2009-October 2010. Reports were analyzed according to complication type, frequency, and resolution, if specified. These data were compared with data on StarClose SE device complications, which included three prospective randomized trials and five prospective nonrandomized trials.
  
  
  RESULTS
  Keyword searches returned 1,107 total records and 1,118 categorizable StarClose SE device complications from the 16-month MAUDE database-reporting period. Complications in order of frequency (absolute number and relative frequency, respectively) included failure to achieve hemostasis (409, 36.6%), inability to complete the deployment sequence (268, 24.0%), entrapped deployment device (224, 20%), clip not deployed (151,13.5%), late bleeding or oozing from dermatotomy site (25, 2.2%), vessel occlusion (19, 1.7%), retroperitoneal hematoma (12, 1.1%), pseudoaneurysm formation (6, 0.5%) and death (4, 0.4%). The distribution of complications differed appreciably from the combined adverse events compiled from the published trials evaluating the StarClose SE device. There were no records describing inability to remove the deployment device in the published trials, whereas this represented the third most common complication reported to the MAUDE database. Bleeding or oozing from the dermatotomy site, the most frequent relative complication reported in the published literature (53.4%), represented 2.2% of the total complications reported to the MAUDE database.
  
  
  CONCLUSIONS
  The type and frequency of complications reported in the MAUDE database on the StarClose SE vascular closure device differ from those published in clinical trials both in relative distribution and in type. Although these differences may reflect in part reporting biases, the distribution of complications reported to the MAUDE database may represent useful information in the use of this device.
authors.affiliation: Department of Radiology and Biomedical Imaging, University of California, San Francisco, San Francisco, CA 94143-0628, USA. thor.johnson@ucsf.edu
authors.forename: D Thor
authors.initials: DT
authors.lastname: Johnson
authors.forename: Jeremy C
authors.initials: JC
authors.lastname: Durack
authors.forename: Nicholas
authors.initials: N
authors.lastname: Fidelman
authors.forename: Robert K
authors.initials: RK
authors.lastname: Kerlan
authors.forename: Jeanne M
authors.initials: JM
authors.lastname: LaBerge
mesh_terms: D016208:Databases, Factual; D057510:Endovascular Procedures / Q000009:adverse effects*; D004867:Equipment Design; D019317:Evidence-Based Medicine; D006470:Hemorrhage / Q000209:etiology / Q000517:prevention & control*; D006489:Hemostatic Techniques / Q000009:adverse effects* / Q000295:instrumentation*; D006801:Humans; D011677:Punctures; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States; D014486:United States Food and Drug Administration